510(k) Report

510(k) · Cleared

Cleared

Neo Nest

K112547510(k) TraditionalCleared Mar 6, 2012187-day reviewClass I21 CFR 890.5710

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Denovo Proucts, LLC · IMD Pack, Hot Or Cold, Disposable

Cleared on Mar 6, 2012 after a 187-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided
Mar 6, 2012
Review
187 days
Class
Class I
Product code
IMD
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2022: 1 descendant cleared2010201520202025
  1. This deviceK112547 Neo NestDenovo Proucts, LLC · 2012
  2. Descendant · cites it directly · 1 of its ownK163295 Infant Transport Mattress Warmer with DiscRapid Aid Corp. · 2017
  3. Descendant · 2 generations on · 0 of its ownK221653 InfaTherm Disposable Infant Warming MattressInternational Biomedical · 2022

Most influential descendants

Showing 2 of 2 · See all
  • K163295Infant Transport Mattress Warmer with DiscRapid Aid Corp. · 2017 · cites it directly1descendant
  • K221653InfaTherm Disposable Infant Warming MattressInternational Biomedical · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K112547Neo NestDenovo Proucts, LLC2012—
+1K163295Infant Transport Mattress Warmer with DiscRapid Aid Corp.2017—
+2K221653InfaTherm Disposable Infant Warming MattressInternational Biomedical2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202210
FIG. 1 — Lineage of K112547, 2012–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IMD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IMD device

  1. #1 K221653 InfaTherm Disposable Infant Warming Mattressscore 4.4 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K163295Infant Transport Mattress Warmer with DiscRapid Aid Corp.20171

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K163295 (Rapid Aid Corp., 2017) has gone furthest, with 1 descendant of its own.

How does its category compare?

All IMD devices

IMD Pack, Hot Or Cold, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · IMD

1in 2022

2007: 12008: 12012: 12017: 12022: 1
2007high 1 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IMD

Too few IMD 510(k)s in any year since 2007 to give a median.

Recalls per year · IMD

4in 2021

2008: 42010: 12015: 12018: 32021: 4
2007high 4 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IMD

66in 2025

2007: 2112008: 8042009: 2102010: 582011: 702012: 532013: 402014: 332015: 1932016: 2132017: 2342018: 2622019: 6322020: 2482021: 1422022: 2022023: 1842024: 1122025: 66
2007high 804 (2008) · low 33 (2014)2025

MAUDE reports naming product code IMD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—0211
20081—4804
20090—0210
20100—158
20110—070
20121—053
20130—040
20140—033
20150—1193
20160—0213
20171—0234
20180—3262
20190—0632
20200—0248
20210—4142
20221—0202
20230—0184
20240—0112
20250—066
20260—0—

What is it indicated for?

Provision of warmth during transport of infant within the hospital or between hospitals.

Recommended for full term infants.

Indications for use as stated in the FDA 510(k) statement.

Recent decisions in IMD

The IMD category page

  • K221653InfaTherm Disposable Infant Warming MattressInternational Biomedical · 2022
  • K163295Infant Transport Mattress Warmer with DiscRapid Aid Corp. · 2017
  • K082087Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2008
  • K071710Bengay (R) Heat Therapy, Pain Relieving Patches/Pads (Various)Johnson & Johnson Consumer Products, Inc. · 2007
  • K021843Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2002

https://510kreport.com/device/K112547 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112547: Neo Nest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112547

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026